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Synthes (usa) Products Llc Recalls

92 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Synthes (usa) Products Llc.

92Total Recalls
1Critical
122.5MUnits Affected
Feb 25, 2026Most Recent
All Recalls

Every Synthes (usa) Products Llc Recall

Sorted by most recent. Click any recall for full details.

92 recalls
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Medical Devices·139 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
Medical Devices·2,157 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with St...
Medical Devices·41 affected·Jun 28, 2016
High RiskFDA
Synthes (usa) Products Llc
Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017...
Surgical Devices·2,064 affected·Jun 7, 2016
High RiskFDA
Synthes (usa) Products Llc
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904...
Medical Implants·383 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synt...
Medical Implants·36 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe...
Medical Implants·19 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Produ...
Medical Implants·79 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usag...
Medical Implants·18 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synt...
Medical Implants·18 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Pro...
Medical Implants·75 affected·May 31, 2016
High RiskFDA
Synthes (usa) Products Llc
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are ...
Medical Devices·599 affected·May 23, 2016
High RiskFDA
Synthes (usa) Products Llc
TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plate...
Medical Devices·182 affected·May 23, 2016
High RiskFDA
Synthes (usa) Products Llc
TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plat...
Medical Devices·90 affected·May 23, 2016
High RiskFDA
Synthes (usa) Products Llc
TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are...
Medical Devices·274 affected·May 23, 2016
High RiskFDA
Synthes (usa) Products Llc
Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are n...
Medical Devices·2,098 affected·May 11, 2016
High RiskFDA
Synthes (usa) Products Llc
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Surgical Devices·244 affected·May 2, 2016
High RiskFDA
Synthes (usa) Products Llc
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instru...
Medical Devices·7,363 affected·Apr 18, 2016
High RiskFDA
Synthes (usa) Products Llc
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Medical Implants·15 affected·Apr 4, 2016
High RiskFDA
Synthes (usa) Products Llc
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating Sy...
Medical Devices·500 affected·Feb 23, 2016
High RiskFDA
Synthes (usa) Products Llc
4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended fo...
Medical Devices·19,497,844 affected·Feb 16, 2016
High RiskFDA
Synthes (usa) Products Llc
4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixat...
Medical Devices·19,497,844 affected·Feb 16, 2016
High RiskFDA
Synthes (usa) Products Llc
6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture f...
Medical Devices·19,497,844 affected·Feb 16, 2016
High RiskFDA
Synthes (usa) Products Llc
7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for...
Medical Devices·19,497,844 affected·Feb 16, 2016
High RiskFDA
Synthes (usa) Products Llc
6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture f...
Medical Devices·19,497,844 affected·Feb 16, 2016
High RiskFDA
Synthes (usa) Products Llc
3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for...
Medical Devices·19,497,844 affected·Feb 16, 2016
High RiskFDA
Synthes (usa) Products Llc
Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, L...
Medical Devices·30 affected·Jan 6, 2016
High RiskFDA
Synthes (usa) Products Llc
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 ...
Medical Devices·378 affected·Dec 8, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 ...
Medical Devices·289 affected·Dec 8, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 ...
Medical Devices·200 affected·Dec 8, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Surgical Devices·65 affected·Dec 1, 2015
High RiskFDA
Synthes (usa) Products Llc
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and...
Medical Devices·229 affected·Nov 2, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum follo...
Medical Devices·267 affected·Oct 19, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
Medical Implants·20,494 affected·Oct 8, 2015
High RiskFDA
Synthes (usa) Products Llc
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fr...
Medical Devices·98 affected·Oct 6, 2015
High RiskFDA
Synthes (usa) Products Llc
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Medical Devices·1,550 affected·Sep 3, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattac...
Medical Devices·105,882 affected·Aug 31, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment f...
Medical Devices·5,306,080 affected·Jul 29, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are sy...
Medical Devices·1,113 affected·Jul 29, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum followi...
Medical Devices·451 affected·Jul 22, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especi...
Surgical Devices·12 affected·Nov 6, 2014
CriticalFDA
Synthes (usa) Products Llc
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix...
Medical Devices·24 affected·Oct 23, 2014
High RiskFDA
Synthes (usa) Products Llc
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part o...
Medical Devices·55 affected·Oct 14, 2013
High RiskFDA
Synthes (usa) Products Llc
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is...
Medical Devices·119 affected·May 31, 2013